Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

NCT06841900 | Not Yet Recruiting

• 1 other identifier: ICF in Paediatric CI users
• Study Type: observational
• Target: 120
• Locations: 6 countries
• Sites: 6

Brief Summary

The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.

Conditions

Cochlear Impant Children

Outcome Measures

Primary Outcomes (7)

• Change in LittlEARS® Auditory Questionnaire (LEAQ)

  The LittlEARS® Auditory Questionnaire (LEAQ) was created to aid professionals and caregivers in the assessment of auditory capabilities among infants and toddlers experiencing hearing impairment. Grounded in the observations made by caregivers concerning the auditory responses exhibited by their children in everyday settings, this questionnaire comprises 35 questions tailored to specific age groups, necessitating responses of either 'yes' or 'no'. These questions are designed to capture significant milestones in auditory development during the initial two years of life or within the first two years following the onset of hearing intervention for children utilizing hearing devices. The questionnaire is suitable for children up to 24 months old, or with a hearing age of 24 months.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P)

  The original SSQ was adapted for use in children, resulting in the development of the SSQ-P. Each of the 23 items in the questionnaire presents a scenario followed by a question regarding the child's hearing ability within that scenario. These items are categorized into three dimensions: speech perception, spatial hearing, and qualities of hearing. Parents are tasked with providing a rating between 0 and 10 for each item, where 0 signifies that the child could not perform in the scenario at all and 10 indicates perfect performance. Additionally, parents are asked to indicate how frequently the scenario would occur and to rate the importance of the listening skills required for that scenario.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Change in Speech Intelligibility Rating (SIR)

  The Speech Intelligibility Rating (SIR) comprises spoken passages, wherein the degree of intelligibility is evaluated using an interval scale spanning from 0 to 10, ensuring uniformity in rating perception. The SIR assessment uses 20 standardized passages delivered by a single speaker, each identified as possessing comparable levels of intelligibility. The SIR is typically used in children with hearing loss from around the age of 2 years old .

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Parent's Evaluation of Aural/Oral Performance of Children (PEACH)

  The PEACH is a 13-item questionnaire designed for parental assessment of a 3- to 7-year-old child's aural and oral abilities in everyday life. The PEACH asks parents to consider their child's listening behaviors over the past week and then assigns a numerical value to the answers ranging from 0 (Never or 0 %) to 4 (Always or 75 to 100 %). The PEACH questions assess listening behaviors in both quiet and noisy surroundings.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry

  Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry will be performed according to current clinical standards (ISO 8253-1, 2010), depending on the age of the participant. Pre- and postoperatively, best-aided audiometry will be measured at 250, 500, 1000, 2000, 4000 and 8000 Hz using warble tones in sound field in a sound treated booth. The loudspeaker will be placed in front of the participant at ear level at 1 meter distance. The best-aided pure tone average (PTA4, primary outcome measurement) will be calculated by averaging participants' hearing thresholds at 500, 1000, 2000 and 4000 Hz in best-aided condition.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Auditory Brainstem Response (ABR) Audiometry

  ABR audiometry involves the generation of an evoked potential through a brief auditory stimulus (e.g., click, chirp, etc.) transmitted via an acoustic transducer (insert earphone or headphone). The resulting waveform response is detected by surface electrodes positioned at the vertex of the scalp and ear lobes. The signal's amplitude is averaged and plotted against time and waveform peaks are identified as I-VII. These waveforms typically occur within a 10-millisecond window following a click stimulus presented at high intensities (70-90 dB normal hearing level \[nHL\]). ABR audiometry is suitable for children of all ages.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

• Ling Sounds (detection/discrimination)

  For Ling sound detection, the participants' detection of six sounds (oo, ah, ee, mm, sh, ss) will be observed in a variety of game formats. In the clinic, each sound is presented six times without lipreading, and the child simply responds. Score "S" will be given if the skill is emerging, score "A" will be given if the child has been observed to carry out the tasks consistently. For Ling discrimination, the phoneme "ee" will be repeated and all six Ling Sounds will be randomly inserted. Score "S" will be given if the child is consistently able to discriminate any one sound out of the six, score "A" will be given if the child is consistently able to discriminate all six sounds. The Ling test is suitable for children from approximately 6 months of age to adulthood.

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

Secondary Outcomes (1)

• Subject Demographics

  1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

Study Arms (1)

Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss

Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss

Device: Cochlear Implantation

Interventions

Cochlear Implantation DEVICE

Standard cochlear implantation

Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss

You may qualify if:

• General
• Children aged \< 18 years with prelingual bilateral severe-to-profound HL
• Signed and dated informed consent, informed permission and/or minor's assent.
• Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
• Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
• Audiological
• Completion of hearing assessment battery showing suitability of the CI candidates.
• Compliance with cochlear implant candidate selection criteria of the implanting centre.
• First cochlear implantation Medical
• Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

You may not qualify if:

• General
• Re-implantation of the cochlear implant
• No motivation to participate in the study and/or unreasonable expectations. Medical
• Presence of contra-indications for surgery in general and cochlear implantation in particular.
• Presence of central auditory lesions.
• Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
• Compressed
• Split
• Any type of custom made electrodes

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (6)

Fiona Stanley Fremantle Hospital Group

Perth, Australia

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

University Clinic of Würzburg

Würzburg, Germany

Location

World Hearing Centre

Warsaw, Poland

Location

King Abdullah Ear Specialist Center (KAESC)

Riyadh, Saudi Arabia

Location

Hospital La Paz

Madrid, Spain

Location

MeSH Terms

Interventions

Cochlear Implantation

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Central Study Contacts

Ellen Andries, PhD AUD

CONTACT

+32 3 275 7372; ellen.andries@uza.be

Griet Mertens, PhD AUD

CONTACT

griet.mertens@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); PL (1); SA (1); BE (1); ES (1); DE (1)